CODEINE PHOSPHATE INJECTION USP LIQUID
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
16-12-2019
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ingredients actius:
CODEINE PHOSPHATE
Disponible des:
SANDOZ CANADA INCORPORATED
Codi ATC:
R05DA04
Designació comuna internacional (DCI):
CODEINE
Dosis:
30MG
formulario farmacéutico:
LIQUID
Composición:
CODEINE PHOSPHATE 30MG
Vía de administración:
INTRAMUSCULAR
Unidades en paquete:
10X1ML/25X1ML
tipo de receta:
Narcotic (CDSA I)
Área terapéutica:
OPIATE AGONISTS
Resumen del producto:
Active ingredient group (AIG) number: 0104398004; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2005-08-11
Fitxa tècnica
_Codeine Phosphate Injection USP _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
CODEINE PHOSPHATE INJECTION USP
Codeine Phosphate
Solution for Injection 30mg/mL
USP
Opioid Analgesic–Antitussive
Sandoz Canada Inc.
Date of Revision:
110 Rue de Lauzon
December 16, 2019
Boucherville, QC, Canada
J4B 1E6
Submission Control No: 225996
_Codeine Phosphate Injection USP _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
PART III: CONSUMER MEDICATION INFORMATION
..................................................26
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